水平: Associate
工作类型: Full-time
工作内容
Description:
In this function:
You will be involved in a small team and you will be responsible for carrying out activities that are necessary for the qualification of GMP materials (raw materials, filters, bags, etc.), services and suppliers.
You report to the Supply Chain Workstream Lead and work closely with the other BIVV001 Workstreams (Tech Transfer, Manufacturing, Quality, ...) and with Suppliers to collect, evaluate and document information about materials with the aim of qualifying the materials for the intended use. Also writing material spec sheets and Quality Agreements, participating in project deliverables such as Fit/Gap assessments, Onboarding report, KPIs, ... and following up a detailed planning are part of your tasks.
All this must be done according to predefined procedures and Sanofi standards and cGMP regulations.
Main responsibilities:
- Aligning needs with internal users and requesting information from suppliers
- Determining the qualification approach for new materials, services and suppliers, taking into account compendial and other regulatory requirements
- Evaluating the qualification results (supplier documentation package, test results, audit reports,....) and writing qualification reports
- Management of extractable/leachable studies and reports
- Follow up method validations of Release Tests
- Follow up Master Data creation (SAP, Lims, ...)
- Writing Material Spec Sheets
- Writing Quality Agreements
- Evaluate and resolve discrepancies and issues during qualification
Profile:
- Master in a scientific direction, or equivalent through experience
- Min. 3-5 years relevant experience
- Knowledge of cGMP in a regulated environment
- Documentation/administration doesn’t scare you
- Knowledge of compendial requirements is a plus
-You are a go-getter with strong analytical and problem-solving abilities
- You take the initiative yourself
- You are result-oriented, flexible and work independently within the set objectives
- You have good social and communication skills and you speak and write Dutch and English fluently
最后期限: 31-12-2025
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